Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study) (MOCC)

Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)

In this feasibility study, the investigators will randomize preterm infants born at <32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infant
• Intervention / Treatment: Procedure: MOCC Group; Procedure: DCC Group

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walid El-Naggar, MD; Phone Number: 902-470-7961; Email: walid.el-naggar@iwk.nshealth.ca
• Study Contact Backup: Name: Jon Dorling, MD; Phone Number: 902-470-6643; Email: Jon.Dorling@iwk.nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Centre
      • Contact: Walid El-Naggar, MD; Phone Number: 902-470-7961; Email: walid.el-naggar@iwk.nshealth.ca
      • Contact: Jon Dorling, MD; Phone Number: 902-470-6643; Email: Jon.Dorling@iwk.nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 minute (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants <32 weeks' gestation

Exclusion Criteria:

• Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
• Monochorionic twins or any higher order multiple pregnancy
• Major fetal congenital or chromosomal abnormality
• Documented fetal anemia or in utero red blood cell transfusion
• Intent to withhold or withdraw treatment of the infant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOCC Group; The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.	Procedure: MOCC Group; After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.; Other Names: Monitoring cerebral oxygenation by NIRS
Active Comparator: DCC group; The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.	Procedure: DCC Group; The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.; Other Names: Monitoring cerebral oxygenation by NIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of compliance to the study intervention	to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.	Two years
Number of patients completing the study	To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT.	Two years
Number of adverse events associated with the MOCC intervention	To investigate any adverse events that could be attributed to the MOCC intervention.	Till the participants reach 2 year- corrected age (around 4.5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare hemoglobin (Hgb) concentration	to compare hemoglobin (Hgb) concentration on NICU admission in preterm infants <32 weeks' gestation who receive MOCC during resuscitation/stabilization following 30 seconds of DCC with those who receive DCC alone for 30-60 seconds at birth (standard practice-control group).	From date of randomization and assessed up to 24 hours of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature stability	Temperature on admission to NICU	From randomization assessed up to 2 hours of age
Need for advanced resuscitation at birth	Need for advanced resuscitation including intubation, chest compressions and/or medications	From randomization assessed up to 2 hours of age
Inotropic support	Need for inotropic medication support	From randomization assessed up to 72 hours of age
Volume expander	Assess the need for a volume expander (saline bolus or albumin bolus)	From randomization assessed up to 72 hours of age
Cerebral oxygenation	Measure the cerebral oxygenation using NIRS	From randomization assessed up to 72 hours of age
Blood transfusion	Assess the number of blood transfusions baby received from birth	From randomization assessed up to 36 weeks corrected gestational age
Intraventricular hemorrhage (IVH)	Assess the grade of IVH	From randomization assessed up to 36 weeks corrected age
Long-term outcomes	Long-term neurodevelopmental outcomes at 18-24 months of corrected age.	24 Months Corrected age

Collaborators and Investigators

• Sponsor: IWK Health Centre
• Investigators: Principal Investigator: Walid El-Naggar, IWK Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Anticipated): February 7, 2021
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: preterm infant; resuscitation; delayed cord clamping; cord milking
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: MOCC Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No